The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia Chemistry Alpha-1 Antitrypsin Assay.
| Device ID | K031857 |
| 510k Number | K031857 |
| Device Name: | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | DEM |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2003-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596228 | K031857 | 000 |
| 00630414517728 | K031857 | 000 |